ArteraAI

The model is the test. There is no assay, no additional tissue collection, and no separate laboratory chemistry: the product reads a digitized image of a biopsy the patient already had, combines it with routine clinical variables, and outputs a risk score. Remove the model and nothing remains.

Correctly bounded by construction. The test produces a risk estimate and a therapy benefit prediction that inform a decision made by clinician and patient together, and the NCCN positioning is explicit that it is used in addition to NCCN risk category, individual patient characteristics, and patient preference. It does not select treatment. For a tool influencing whether a patient receives androgen deprivation therapy alongside radiation, decision support is the right ceiling and the guideline language enforces it.

The algorithm is described as pre established and locked at a stated version, which is the disclosure that matters most for a clinical model and is almost absent elsewhere in this index. A locked algorithm cannot drift silently between the validation study and the patient in front of you, and versioning means a published result can be attributed to a specific model. Inputs are fully enumerated, being digital histopathology plus age, PSA, and tumor stage, and the output is a continuous score from 0 to 1 with published cut points tied to explicit ten year risk thresholds of roughly 3 and 10 percent. A clinician can therefore see what went in, what came out, and what the number means.

The strongest evidence position of any vendor in this index. Inclusion in the NCCN Clinical Practice Guidelines for Prostate Cancer as the first and only AI risk stratification tool, carrying a Level 1B evidence rating under Simon Criteria and a Category 2A recommendation reflecting uniform NCCN consensus. Models were developed and validated on multiple phase 3 randomized controlled trials with up to 15 years of follow up, with published results showing 9.2 to 14.6 percent relative improvement over NCCN standard methods at a median 11.4 years. Independent validation in a prospective real world prostatectomy cohort has been published, as has a cost effectiveness analysis in a JNCI journal by an academic group unaffiliated with the company. Guideline inclusion is a materially higher bar than any vendor claim, because a guideline panel evaluates the evidence rather than the marketing.

FDA De Novo marketing authorization granted August 2025. De Novo matters more than a 510(k) here because it means there was no predicate device to compare against, so the agency reviewed the evidence directly and created a new classification. This is the strongest regulatory position in the index alongside Aidoc's cleared foundation model, and it stands in deliberate contrast to Techcyte in the same category, whose comparable products remain Research Use Only in the United States.

Better than most in this index on the question that determines whether a test is actually usable: CMS coverage with an established payment rate effective January 2024 means a reimbursement pathway exists rather than a cash pay burden on the patient or the practice. An independent cost effectiveness analysis has also been published in a peer reviewed JNCI journal, which is a form of price justification almost no vendor here can point to. Held back from A because no list price or commercial payer coverage detail was retrieved.

Deliberately narrow and better for it: localized and nonmetastatic prostate cancer, extended in June 2026 to metastatic hormone sensitive disease. Depth in one disease is what produced guideline inclusion, and buyers should read the narrowness as evidence of rigour rather than limitation. Graded B only because coverage is single disease; a center seeking broad oncology decision support needs other tools alongside it.